The present invention is the use of a paracetamol formulation that has unexpectantly been shown to have improved pharmacokinetic profiles in patients having gastric dysmotility or gastroparesis. Historically, diabetes has been shown to reduce gastric motility (gastroparesis) by up to 50% in patients as compared to non-diabetic individuals.
Involvement of the autonomic nervous system in patient having diabetes mellitus includes gastric enteropathy characterized by gastrointestinal dysmotility. Bassotti, G., Recenti Prog Med. 82: 334-337 (1991). Long-standing diabetes mellitus may reduce gastric emptying in up to 50% of patients. O'Mahony et al., Drugs Aging, 19: 515-527 (2002). The impact of various age-related diseases on gastrointestinal motility in the elderly can also include those patients with depression which significantly prolongs whole-gut transit time; hypothyroidism, chronic renal failure, and idiopathic Parkinson's disease. Frequently drugs in the elderly can cause disordered gastrointestinal motility, such as anticholinergics, opioid analgesics and calcium antagonists.
The importance of dysmotility in patients, particularly the elderly, may result in serious clinical consequences where clinical response to a medication is delayed, such as in delayed levodopa absorption or with diuretics. As opioids and anticholinergics already have inhibitory effects on gastric emptying, this may delay the absorption of other drugs. Consequently, the need for consistent, low intrapatient variability on absorption of drugs, such as analgesics, in such a patient population is very much in need.